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510(k) K955339

HYDROLOGY 5000 by Northgate Technologies, Inc. — Product Code GBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1996
Date Received
November 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
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